Pacemaker reclassification, Electrical Stimulators ban
FDA BRIEF: Week of April 18, 2016
External Pacemaker Pulse Generator Devices
Reclassified from Class III to Class II
Based on:
- Review of the MAUDE safety database and recall data
- Review of current scientific literature
- 2013 Circulatory System Devices Panel deliberations
- Special controls, in conjunction with general controls, will provide reasonable assurance of the safety and effectiveness
Electrical stimulation devices intended to treat self-injurious or aggressive behavior
Proposal to BAN
Based on:
- Review of clinical and scientific data, input from experts, treated individuals and their parents, disability rights groups, 2014 FDA advisory panel
- Unreasonable and substantial risk to public health
- Risk cannot be corrected or eliminated through labeling
- Alternative approaches available – Positive behavioral support, medications
FDA will work with health care providers to facilitate safe transition to alternate care